N.M. Admin. Code § 7.34.4.18

Current through Register Vol. 35, No. 21, November 5, 2024

Section 7.34.4.18 - DEPARTMENT-APPROVED TESTING LABORATORIES; GENERAL OPERATIONAL REQUIREMENTS

A.Receipt of test samples: An approved laboratory may receive test samples of cannabis or cannabis derived products from any licensed producer, qualified patient or primary caregiver, and shall apply the testing standards of this rule, including the testing parameters, action levels, reporting levels, and other criteria identified in Tables 1 through 6, to determine whether a sample passes a given test.

B.Testing policies: An approved laboratory or laboratory applicant shall establish and implement policies for sample preparation, documentation, and transport, including:

(1) accepted test sample types;

(2) minimum test sample size;

(3) recommended test sample container;

(4) test sample labeling;

(5) transport and storage conditions, such as refrigeration, as appropriate;

(6) other requirements, such as use of preservatives, inert gas, or other measures designed to protect sample integrity; and

(7) creation of chain of custody documentation for each sample.

C.Recording of samples received: An approved laboratory shall:

(1) record the receipt of every test sample received, the record of which shall include:

(a) the name and contact information of the licensed producer that was the source of the sample;

(b) an appropriately specific description of the sample;

(c) the date of receipt of the sample;

(d) a statement of the quantity (weight, volume, number, or other amount) of the sample; and

(e) a batch number or code that is associated with the product batch and that is recorded by the non-profit producer or manufacturer in the electronic tracking system specified by the department.

(2) inform each licensed producer or individual who submits a test sample of the policies established in accordance with this section.

D.Sample handling, storage and disposal: An approved laboratory shall establish sample handling procedures for the tracking of test samples through the analytical process (by weight, volume, number, or other appropriate measure) to prevent diversion.

(1) An approved laboratory shall store each test sample under the appropriate conditions to protect the physical and chemical integrity of the sample.

(2) Analyzed test samples consisting of cannabis or cannabis-derived product shall be appropriately segregated, controlled, and held in a controlled access area pending destruction or other disposal.

(3) Any portion of a cannabis or cannabis-derived test sample that is not destroyed during analysis shall be:

(a) returned to the licensed producer who provided the sample; or

(b) destroyed in accordance with the wastage requirements of this rule.

E.State and local laws: An approved laboratory and a laboratory applicant shall comply with all applicable state and local laws, including but not limited to zoning, occupancy, licensing, and building codes.

F.Laboratory premises: An approved laboratory and a laboratory applicant shall maintain the premises of the laboratory in a clean and orderly condition; shall equip the premises with such utensils and equipment as necessary to conduct the operations of the laboratory; and shall ensure adequate space for laboratory operations, sample storage, and document storage.

G.Storage: An approved laboratory and a laboratory applicant shall be equipped with one or more secure, controlled access areas for storage of cannabis and cannabis-derived product test samples, cannabis-derived waste, and reference standards. Access to such storage areas shall be limited by the laboratory to authorized individuals.

H. Equipment:

(1) Equipment used for the analysis of test samples shall be adequately inspected, cleaned, and maintained. Equipment used for the generation or measurement of data shall be adequately tested and calibrated on an appropriate schedule, as applicable.

(2) Laboratory operations shall document procedures setting forth in sufficient detail the methods and schedules to be used in the routine inspection, cleaning, maintenance, testing, and calibration of equipment, and shall specify, as appropriate, remedial action to be taken in the event of failure or malfunction of equipment. The procedures shall designate the personnel responsible for the performance of each operation.

(3) Records shall be maintained of all inspection, maintenance, testing, and calibrating operations. These records shall include the date of the operation, the person who performed it, the written procedure used, and any deviations from the written procedure. Records shall be kept of non-routine repairs performed on equipment as a result of failure and malfunction. Such records shall document the nature of the repair, how and when the need for the repair was discovered, and any remedial action taken in response to the repair.

(4) Computer systems used for the analysis of samples, retention of data, sample tracking, calibration scheduling, management of reference standards, or other critical laboratory management functions shall ensure that electronic records, electronic signatures, and handwritten signatures executed to electronic records are trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.

I.Reagents, solutions, and reference standards:

(1) An approved laboratory is authorized to possess reagents, solutions, and reference standards. Such items shall be:

(a) secured in accordance with the approved laboratory's storage policies; labeled to indicate identity, date received or prepared, and expiration or requalification date; and, where applicable, concentration or purity, storage requirements, and date opened;

(b) stored under appropriate conditions to minimize degradation or deterioration of the material; and

(c) used only within the item's expiration or requalification date.

(2) Deteriorated or outdated reagents and solutions shall be properly destroyed.

(3) An approved laboratory may acquire commercial reference standards for cannabinoids and other chemicals or contaminants, for the exclusive purpose of conducting testing for which the laboratory is approved. An approved laboratory may elect to internally produce reference standards. When internally produced, an approved laboratory shall utilize standard analytical techniques to document the purity and concentration of the internally produced reference standards. An approved laboratory is authorized to obtain cannabis or cannabis-derived product from a licensed non-profit producer for this purpose.

(4) An approved laboratory shall obtain or, for internally-produced standards, shall create a certificate of analysis (COA) for each lot of reference standard. Each COA shall be kept on file and the lot number of the reference standard used shall be recorded in the documentation for each analysis, as applicable.

J.Analysis: An approved laboratory shall:

(1) utilize analytical methods that are appropriate for the purpose of testing cannabis and cannabis-derived products;

(2) require analysts to demonstrate proficiency in the performance of the analytical methods used;

(3) maintain written procedures for the analytical method used for the analysis of each test sample, including:

(a) sample preparation;

(b) reagent, solution, and reference standard preparation;

(c) instrument setup, as applicable;

(d) standardization of volumetric reagent solutions, as applicable;

(e) data acquisition; and

(f) calculation of results.

(4) specify, as applicable to each analytical method used, requirements for accuracy, precision, linearity, specificity, limit of detection, limit of quantitation, and other data quality parameters;

(5) ensure that no deviations from approved protocols or standard operating procedures are made during any analytical process without proper authorization and documentation; and

(6) use only primary standards or secondary standards for quantitative analyses.

K.Recording of analytical data:

(1) An approved laboratory shall ensure that all data generated during the testing of a test sample, except data generated by automated data collection systems, is recorded directly, promptly, and legibly in ink. All data shall be annotated with the date of entry and signed or initialed by the person recording the data. Any change in entries shall be made so as not to obscure the original entry, shall indicate the reason for such change, and shall be dated and signed or initialed at the time of the change.

(2) In automated data collection systems, the individual responsible for direct data input shall be identified at the time of data input. Any change in an entry shall be made so as not to obscure the original entry, shall indicate the reason for such change, and shall be dated and signed or initialed at the time of the change. A corrective action report (CAR) shall accompany such change and shall be made available to the department, a non-profit producer, and a manufacturer upon their request for up to two years after the analysis is completed.

(3) For each final result reported, an approved laboratory shall verify that:

(a) any calculations or other data processing steps were performed correctly;

(b) the data meet any data quality requirements such as for accuracy, precision, linearity, etc.;

(c) any reference standards used were of the appropriate purity and within their expiration or requalification dates;

(d) any volumetric solutions were properly standardized before use; and

(e) any test or measuring equipment used has been properly tested, verified, and calibrated, and is within its verification or calibration period.

L.Data storage:

(1) An approved laboratory shall ensure that all raw data, documentation, protocols, and final reports associated with analysis of a test sample are retained for two years from the date of the completion of analysis.

(2) An approved laboratory shall maintain the records identified in this section. Such records must be maintained:

(a) in a manner that allows retrieval as needed;

(b) under conditions of storage that minimize deterioration throughout the retention period; and

(c) in a manner that prevents unauthorized alteration.

M.Records maintenance and access: An approved laboratory or laboratory applicant shall designate an individual as responsible for records maintenance. Only authorized personnel may access the maintained records.

N.Data reporting:

(1)Contents of report: A laboratory report of a test conducted at the request of a licensed producer or qualified patient shall contain the following information:

(a) the date of receipt of the test sample;

(b) the description of the type or form of the test sample (leaf, flower, powder, oil, specific edible product, etc.);

(c) the batch number or code that is associated with the product batch and that is recorded in the electronic tracking system specified by the department;

(d) information on whether sampling was performed by the laboratory operation, by the compliant business or individual which submitted the test sample, or by a third-party;

(e) date on which analysis occurred;

(f) the analytical method used, including at a minimum identification of the type of analytical equipment used (e.g., GC, HPLC, UV, etc.);

(g) the analytical results, including units of measure where applicable;

(h) the identity of the supervisory or management personnel who reviewed and verified the data and results and ensured that data quality, calibration, and other applicable requirements were met; and

(i) the name, address, and contact information of the approved laboratory that conducted the test.

(2) The laboratory report shall state that reported analytical results apply only to the test sample received.

O.Department access to materials and premises: An approved laboratory shall promptly provide the department or the department's designee access to a report of a test, and any underlying data, that is conducted on a sample at the request of a licensed producer or qualified patient. An approved laboratory shall also provide access to the department or the department's designee to laboratory premises, and to any material or information requested by the department, for the purpose of determining compliance with the requirements of this rule.

P.Drugs and alcohol: A laboratory shall prohibit its employees and contractors from being under the influence of drugs or alcohol in the workplace.

Q.Failures to meet testing requirements: Repeated failures by a laboratory to comply with the testing requirements of department rule may result in disciplinary action against the laboratory.

N.M. Admin. Code § 7.34.4.18

7.34.4.18 NMAC - Rp, 7.34.4.16 NMAC, 12/30/2010, Amended by New Mexico Register, Volume XXVI, Issue 04, February 27, 2015, eff. 2/27/2015, Amended by New Mexico Register, Volume XXX, Issue 16, August 27, 2019, eff. 8/27/2019, Adopted by New Mexico Register, Volume XXXI, Issue 12, June 23, 2020, eff. 6/23/2020